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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/477399/2014

EMEA/H/C/000088

EPAR summary for the public

Humalog

insulin lispro

This is a summary of the European public assessment report (EPAR) for Humalog. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Humalog.

What is Humalog?

Humalog is a range of solutions and suspensions for injection that contain the active substance insulin lispro and are supplied in vials, cartridges and prefilled pens (Humalog KwikPen). The Humalog range comprises fast-acting insulin solutions (Humalog), longer-acting insulin suspensions (Humalog Basal), and combinations of both in various proportions (Humalog Mix):

•    Humalog: insulin lispro solution, available in a standard or a higher strength (100 or 200 units/ml);

•    Humalog Basal: insulin lispro protamine suspension;

• Humalog Mix25: 25% insulin lispro solution and 75% insulin lispro protamine suspension;

• Humalog Mix50: 50% insulin lispro solution and 50% insulin lispro protamine suspension.

What is Humalog used for?

Humalog is used to treat patients who have diabetes and need insulin to keep their blood glucose (sugar) level controlled, including patients whose diabetes has just been diagnosed.

The medicine can only be obtained with a prescription.

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How is Humalog used?

Humalog, Humalog Basal and Humalog Mix may be given by injection under the skin of the upper arm, thigh, buttock or abdomen (tummy). Humalog 100 units/ml may also be given by continuous infusion using an insulin pump or into a vein. Humalog 200 units/ml must only be injected under the skin, using the KwikPen device in which it is supplied.

Humalog and Humalog Mix are normally given shortly before a meal, but they can be given just after a meal if necessary. Humalog can be used with a longer-acting insulin or with sulphonylureas (a group of diabetes medicines that are taken by mouth).

Patients can inject themselves with this medicine if they have been trained appropriately.

For further information, see the package leaflet.

How does Humalog work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. Humalog is a replacement insulin which is very similar to the insulin made by the body.

The active substance in Humalog, insulin lispro, is produced by a method known as 'recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce insulin lispro.

Insulin lispro is very slightly different from human insulin. The difference means that insulin lispro is absorbed faster by the body than human regular insulin, and can therefore act faster. Insulin lispro is available as Humalog in the soluble form, which acts more or less immediately after injection, and as Humalog Basal in the 'protamine suspension' form, which is absorbed much more slowly so that it works for longer. Humalog Mix is a mixture of these two formulations.

The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has Humalog been studied?

Humalog was originally studied in eight clinical trials including 2951 patients with type 1 diabetes (when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively). The effectiveness of Humalog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when added to long-acting insulins given once or twice a day. The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbAlc), which gives an indication of how well the blood glucose is controlled, and 'fasting' blood glucose levels (measured when the patient had not eaten for at least eight hours). Studies also looked at the use of Humalog in 542 patients aged between two and 19 years, and the use of Humalog in combination with sulphonylureas.

What benefit has Humalog shown during the studies?

Humalog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.

What is the risk associated with Humalog?

Humalog may cause hypoglycaemia (low blood glucose levels) and must not be given to patients whose blood glucose is already low. Humalog doses might need to be adjusted when given with other medicines that may have an effect on blood glucose levels.

Humalog Mix, Humalog Basal and Humalog 200 units/ml should never be given into a vein.

For the full list of all side effects and restrictions with Humalog, see the package leaflet.

Why has Humalog been approved?

The Committee for Medicinal products for Human Use (CHMP) decided that Humalog's benefits are greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus. The Committee recommended that Humalog be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Humalog?

A risk management plan has been developed to ensure that Humalog is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Humalog, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that makes Humalog has provided information to patients and healthcare professionals to remind them that there are two strengths of Humalog and to advise them on how to use them safely to avoid medication errors.

Other information about Humalog

The European Commission granted a marketing authorisation valid throughout the European Union for Humalog on 30 April 1996.

The full EPAR for Humalog can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Humalog, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2014.

Humalog

EMA/477399/2014

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